Menup Max

Package Leaflet: Information for the Patient

MenUp Max, 100 mg, Film-Coated Tablets

Sildenafil

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet:

• 1. What is MenUp Max and what is it used for
• 2. Important information before taking MenUp Max
• 3. How to take MenUp Max
• 4. Possible side effects
• 5. How to store MenUp Max
• 6. Contents of the pack and other information

1. What is MenUp Max and what is it used for

MenUp Max contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. MenUp Max helps to achieve an erection only if you are sexually stimulated. MenUp Max is used to treat erectile dysfunction in adult men, which is the inability to achieve or maintain an erection sufficient for satisfactory sexual performance.

2. Important information before taking MenUp Max

When not to take MenUp Max

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking nitrates, as this can lead to a dangerous drop in blood pressure. Tell your doctor if you are taking any of these medicines, which are often used to relieve angina (chest pain). If in doubt, consult your doctor or pharmacist.
• If you are taking medicines that release nitric oxide, such as amyl nitrite (so-called "poppers"), as this can also lead to a dangerous drop in blood pressure.
• If you are taking riociguat, which is used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by blood clots). It has been shown that PDE5 inhibitors, such as MenUp Max, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, tell your doctor.
• If you have severe heart or liver disease.
• If you have recently had a stroke or heart attack, or if you have low blood pressure.
• If you have inherited degenerative eye disease, such as retinitis pigmentosa.
• If you have ever had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Before taking MenUp Max, discuss with your doctor, pharmacist, or nurse if you:

• Have sickle cell anemia (a condition that affects red blood cells), leukemia (a cancer of the blood), or multiple myeloma (a cancer of the bone marrow).
• Have a deformed penis or Peyronie's disease.
• Have heart problems. In this case, your doctor should assess whether your heart is healthy enough for extra strain, such as sexual activity.
• Have ulcers or bleeding disorders (such as hemophilia).
• If you experience sudden vision loss or sudden hearing loss, stop taking MenUp Max and contact your doctor immediately.

MenUp Max should not be taken with other oral or topical treatments for erectile dysfunction. MenUp Max should not be taken with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or other PDE5 inhibitors. MenUp Max should not be taken if you do not have erectile dysfunction. MenUp Max is not intended for use by women. Special considerations for patients with kidney or liver problemsPatients with kidney or liver problems should tell their doctor. The doctor may decide to use a lower dose of MenUp Max.

Children and adolescents

MenUp Max should not be used in people under 18 years of age.

MenUp Max and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take. MenUp Max may interact with some medicines, especially those used to treat chest pain. If your condition gets worse and you need immediate medical attention, tell your doctor, pharmacist, or nurse that you have taken MenUp Max and when you took it. Do not take MenUp Max with other medicines unless your doctor tells you to. Do not take MenUp Max if you are taking nitrates, as this can lead to a dangerous drop in blood pressure. Always tell your doctor, pharmacist, or nurse if you are taking nitrates, which are used to treat angina (chest pain). Do not take MenUp Max if you are taking medicines that release nitric oxide, such as amyl nitrite, as this can also lead to a dangerous drop in blood pressure. If you are already taking riociguat, tell your doctor or pharmacist. If you are taking protease inhibitors, used to treat HIV infections, it is recommended to start with a lower dose (25 mg) of MenUp Max. In some patients who take alpha-blockers for high blood pressure or prostate enlargement, dizziness or fainting may occur, which can be symptoms of low blood pressure, caused by a drop in blood pressure when standing up quickly or sitting down. Such symptoms have occurred in some patients who took sildenafil and alpha-blockers at the same time. They are most likely to occur within 4 hours after taking MenUp Max. To reduce the likelihood of these symptoms, you should regularly take your fixed dose of alpha-blocker before starting to take MenUp Max. Your doctor may decide to use a lower initial dose (25 mg) of sildenafil. If you are taking medicines containing sacubitril with valsartan (used to treat heart failure), tell your doctor or pharmacist.

Taking MenUp Max with food, drink, and alcohol

MenUp Max can be taken with or without food. However, taking MenUp Max with a large meal may delay the onset of action. The ability to achieve an erection may be temporarily impaired after drinking alcohol. To maximize the therapeutic effects of MenUp Max, do not drink large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

MenUp Max is not intended for use by women.

Driving and using machines

MenUp Max may cause dizziness and visual disturbances. Before driving or using machines, you should be aware of how you react to MenUp Max.

MenUp Max contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take MenUp Max

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. The recommended starting dose is 50 mg. Do not take MenUp Max more than once a day.Do not take MenUp Max film-coated tablets in combination with Viagra or other medicinal products containing sildenafil. MenUp Max should be taken approximately one hour before planned sexual activity. Swallow the tablet whole with a glass of water. If you feel that the effect of MenUp Max is too strong or too weak, talk to your doctor or pharmacist. MenUp Max will only work when you are sexually stimulated. The time it takes for MenUp Max to work varies from person to person, but it normally takes between half an hour to one hour. The effect may occur later if you take MenUp Max after a large meal. If you do not get an erection after taking MenUp Max, or if the erection is not sufficient for sexual performance, contact your doctor.

Taking more MenUp Max than you should

You may experience more side effects and they can be more severe. Taking a dose higher than 100 mg does not increase the efficacy of the medicine. Do not take more tablets than your doctor prescribes.If you take more tablets than you should, contact your doctor. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, MenUp Max can cause side effects, although not everybody gets them. Side effects reported in association with the use of MenUp Max are usually mild to moderate and are short-lived.

If you experience any of the following side effects, stop taking MenUp Max and seek medical help immediately:

• Allergic reaction (hypersensitivity) - uncommon(may affect up to 1 in 100 people) Symptoms: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.
• Chest pain - uncommonIf this occurs during or after sexual intercourse:
• sit half-upright and try to relax,
• do not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - rare(may affect up to 1 in 1000 people) If an erection lasts more than 4 hours, seek medical help immediately.

Sudden vision loss or hearing loss - rare

• Severe skin reactions - rareSymptoms can include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or fits - rare

Other side effects: Very common (may affect more than 1 in 10 people):

• Headache.

Common(may affect up to 1 in 10 people):

• Nausea
• Facial flushing
• Hot flushes (symptoms include a feeling of heat in the upper body)
• Indigestion
• Visual disturbances, blurred vision, color tinge to vision
• Stuffy nose
• Dizziness.

Uncommon(may affect up to 1 in 100 people):

• Vomiting
• Rash
• Eye irritation
• Conjunctivitis
• Eye pain
• Seeing flashes of light
• Increased sensitivity to light
• Eye discharge
• Pounding heartbeat
• Fast heartbeat
• High blood pressure
• Low blood pressure
• Muscle pain
• Somnolence
• Decreased sensation of touch
• Dizziness
• Ringing in the ears
• Nausea
• Dry mouth
• Blocked or stuffy nose
• Nasal sinusitis (symptoms include runny nose, sneezing, and stuffy nose)
• Upper abdominal pain
• Gastroesophageal reflux disease (symptoms include heartburn)
• Blood in urine
• Pain in arms or legs
• Nosebleeds
• Feeling hot
• Feeling tired.

Rare(may affect up to 1 in 1000 people):

• Fainting
• Stroke
• Heart attack
• Irregular heartbeat
• Temporary decrease in blood flow to part of the brain
• Feeling of tightness in the throat
• Numbness of the mouth
• Bleeding in the back of the eye
• Double vision
• Decreased sharpness of vision
• Abnormal sensations in the eye
• Swelling of the eyes or eyelids
• Small particles or spots in the field of vision
• Seeing halos around lights
• Dilated pupils
• Abnormal coloration of the white of the eye
• Bleeding from the penis
• Presence of blood in semen
• Dry nose
• Swelling inside the nose
• Feeling irritable
• Sudden loss of hearing.

After marketing, there have been rare reports of unstable angina (heart disease) and sudden death. It is important to note that in most, but not all, of these men, pre-existing heart disease was present before taking MenUp Max. It is not possible to determine whether these events were related to MenUp Max.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MenUp Max

Keep the medicine out of the sight and reach of children. There are no special storage instructions for this medicine. Do not use this medicine after the expiry date stated on the blister and carton after EXP:. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What MenUp Max contains

• The active substance of MenUp Max is sildenafil. Each tablet contains 100 mg of sildenafil (as sildenafil citrate).
• The other ingredients are: Tablet core: microcrystalline cellulose 102, calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate. OPADRY II 32K205007 blue coating: hypromellose 15 mPa⋅s, lactose monohydrate, titanium dioxide (E 171), triacetin, indigo carmine (E 132), aluminum lake.

What MenUp Max looks like and contents of the pack

MenUp Max film-coated tablets are blue, elongated, 16.5 mm/6.5 mm in size, convex on both sides, with the number "100" on one side. PVC/PVDC/Aluminum blisters in a carton containing 2, 4, or 8 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Silesian Pharma Sp. z o.o., ul. Szopienicka 77, 40-431 Katowice, tel: (32) 20 80 600

Manufacturer

Adamed Pharma S.A., ul. Marszałka J. Piłsudskiego 5, 95-200 Pabianice

Date of last revision of the leaflet: